|Publication number||US7682365 B2|
|Application number||US 11/559,043|
|Publication date||Mar 23, 2010|
|Filing date||Nov 13, 2006|
|Priority date||Nov 13, 2006|
|Also published as||US20080114390|
|Publication number||11559043, 559043, US 7682365 B2, US 7682365B2, US-B2-7682365, US7682365 B2, US7682365B2|
|Original Assignee||Medtronic Vascular, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (9), Referenced by (4), Classifications (5), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The invention relates generally to an intra-luminal device for use in crossing a norrowing in a body passageway. More particularly, the invention relates to a catheter device that selectively provides additional stiffness and support to a guidewire for crossing a chronic total occlusion (CTO) in a blood vessel.
Stenotic lesions may comprise a hard, calcified substance and/or a softer thrombus material, each of which forms on and within the lumen walls of a blood vessel and restricts blood flow through the lumen. Intra-luminal treatments such as balloon angioplasty (PTA, PTCA, etc,)) stent deployment, atherectomy, and thrombectomy are well known and have proven effective in the treatment of such stenotic lesions. These treatments often involve the insertion of at therapy catheter into a patient's vasculature, which may be tortuous and may have numerous stenoses of varying degrees throughout its length. In order to place the distal end of a catheter at the treatment site, a guidewire is typically introduced and tracked from an incision, through the vasculature, and across the lesion. Then at catheter (e,g., a balloon catheter), perhaps carrying a stent at its distal end, can be tracked over the guidewire to the treatment site. Ordinarily, the distal end of the guidewire is quite flexible so that it can be rotatably steered and pushed through the bifurcations and turns of the typically irregular passageway without damaging the vessel walls.
In some instances, the extent of occlusion of the lumen is so severe that the lumen is completely or nearly completely obstructed, which may be described as a total occluslon. If this occlusion persists for a long period of time, the lesion is referred to as a chronic total occlusion or CTO. Furthermore in the case of diseased blood vessels, the lining of the vessels may be characterized by the prevalence of atheromatous plaque which may form total occusions. The extensive plaque formation of a chronic total occlusion typically has a fibrous cap surrounding softer plaque material. This fibrout cap tray present a surface that is difficult to penetrate with a conventional guidewire, and the typically flexible distal tip of the guidewire may be unable to cross the lesion.
Thus for treatment of total occlusions, stiffer guidewires have been employed to recanalize through the total occlusion. However due to the fibrous cap of thee total occlusion, a stiffer guidewire still may not be able to cross the occlusion. Further, in a CTO there may be a distortion of the regular vascular architecture, such that there may be multiple small non-functional channels throughout the occlusion rather than one central lumen for recanalizaition. Furthermore these spontaneously recanalized channel may be responsible for failers due to their dead-end pathways, which may misdirect the guidewires. Once a “false” tract is created by a guidewire, subsequently attempts to cross the CTO with different guidewires may continue to follow the same incorrect path as it is very difficult to steer subsequent guidewire away from the false tract.
What is needed is a steerable device that aids in directing a guidewire to an optimum approach for crossing a chronic total occlusion CTO, as well as provides support to the guidewire for pushing the guidewire through the CTO.
Accordingly, disclosed herein is a catheter device that provides additional support to a guidewire for aiding the guidewire in crossing a lesion in a body lumen. The catheter device includes a elongate outer tubular member with a lumen that extends from a proximal end to a distal end thereof. The outer tubular member has a distal end with a tapered portion. The catheter device further includes a guidewire gripping member that is slidably disposed in the lumel of the outer tubal member. The guidewire gripping member has a guidewire lumen for slidably receiving the guidewire and a distal end with a plurality of longitudinal slots defining gripping jaws therein. When the guidewire gripping member is advanced distally within the outer tubular members, the gripping contact the tapered portion of the outer shaft, such that or fingers of the guidewire gripping member to forced to grip with the guidewire to thereby prevent movement of the guidewire relative to the catheter device.
In an embodiment the catheter device includes a steering wire for deflecting a distal end of the catheter device. In a further embodiment, a hub is disposed at a proximal end of the catheter device includes one or more actuation mechanism for advancing and retracting the guidewire gripping member and/or the steering wire within the outer tubular member.
A method of crossing a lesion in a body lumen in accordance with another embodiment of the present invention includes advancing a guidewire through a patient's vasculature to position a distal end of the guidewire proximate to the lesion. A catheter device is then provided that includes an elongate outer shaft with a tapered distal portion and a guidewire gripping member slidably disposed within the outer shaft, wherein the guidewire gripping member includes a guidewire lumen and a longitudinally slotted distal end having gripping jaws or fingers. The catheter device is tracked over the guidewire until distal end of the catheter device is positioned proximate to the distal end of the guidewire. The method further includes engaging the catheter device with the guidewire by distally advancing the guidewire gripping member relative to the outer shaft of the catheter device such that the interactin between the gripping fingers at the distal end of the guidewire gripping member and the tappered distal portion of the outer shaft secures the catheter device to the guidewire. The combined catheter device and guidewire component are then distally pushed through the lesion.
In a method in accordance with another embodiment, the catheter device further includes a steering, wire attached to the distal end of the catheter device, wherein prior to the step of distally advancing the guidewire gripping member relative to the outer shaft of the catheter device, the steering wire is retracted to deflect the distal end of the catheter device so that the combined catheter device and guidewire component may be steered to optimum crossing point in the lesion, prior to the step of pushing the combined catheter device and guidewire component through the lesson.
The foregoing and other features and advantages of the invention will be aparent from the following description of the invention as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale.
Specific embodiments of the present invention are now described figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinican. “Distal” and “distally” are a position distant from or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician.
The present invention is a catheter device for use in conjunction with a guidewire for crossing total occlusion or a chronic total occlusion (CTO). However, it will be understood that the invention is not limited to treatment of CTOs, or to treatment of blood vessels, for that matter. The invention may be useful wherever a clinician encouters difficulty navigating a medical guidewire across a narrowing in a body passageway. The catheter device acts as a catheter providing the guidewire with additional support. The catheter device may selectively secured to the guidewire to allow the guidewire to be pushed into a through the lesion, i.e., the total occlusion or CTO. In various embodiments, the catheter device may be steerable to position the guidewire at an optimal starting point for crossing the CTO.
As illustrated with reference to
Hub 110 includes an actuation button 112 for slidably advancing and retracting guidewire gripping member 206 within outer shaft 102. Actuation button 112 is slidable within an actuation slot 113, which in an embodiment, limits how far distally guidewire gripping member 206 may be advanced. Other types of control mechanisms are possible for slidably advancing and retracting guidewire gripping member 206 within outer shaft 102, as will be understood by those of ordinary skill in the art.
A conventional guidewire 104 removably and slidably extends through a lumen within guidewire gripping member 206. Catheter device 100 is trackable over and selectively securable to guidewire 104 depending on the position of a distal end 205 of guidewire gripping member 206 within outer shaft 102. A plurality of slots 208 extend longitudinally from distal end 205 of guidewire gripping member 206 to define a plurality of flexible, gripping jaws or fingers 211. When distal end 205 is advanced within tapered portion 207 of outer shaft 102, slots 208 between fingers 211 allow fingers 211 to converge as distal end 205 is reduced in diameter and thereby acts like a collet in a pin chuck. As shown in
In an embodiment illustrated in
When catheter device 400 is in the disengaged, open configuration such that distal end 405 of guidewire gripping member 406 is not in contact, or is in sliding contact with tapered portion 407 of outer tubular member 402, steering wire 414 may be retracted, or displaced proximally, to deflect or bend the distal tip of catheter device 400 from a straight configuration into a deflected configuration, for example, as shown in
In another embodiment (not shown), a wall of the outer tubular member of shaft may include a steering wire lumen or channel that accomodates sliding movement of the steering wire and separates the steering wire from the outer shaft lumen containing the guidewire gripping member. In various embodiments of the present invention, such a steering wire channel may extend along an entire length of the outer tubular member, or for some lesser length thereof.
Actuation slot 522 provides a limit to how far distally guidewire gripping member 506 may be pushed/advanced within outer shaft 502 to prevent an over-advancing the distal end of guidewire gripping member 506 that could cause over-stressing or unintentional bending of the tapered portion (not shown) at the distal end of outer shaft 502. In a similar manner, actuation slot 523 provides a limit to how far proximally steering wire 513 may be pulled to avoid breaking the wire and/or over-deflection of the distal end of the cathter device. In
Outer shaft 102 of catheter device 100 is a long, hollow tube that is flexible enough to navigate the tortuous pathways of the cardiovascular system while being longitudinally incompressible enough to be pushed through the vasculature. Outer shaft 102 may include tubing made from a thermoplastic material, such as polyether block amide copolymer (PEBA), polyvinyl chloride, polyethylene, polyethylene terephthalate, polyamide, thermoplastic polyurethan (TPU), or a thermoset polymer such as polyimide, or a combination thereof. Distal tapered portion 207 may be thermoformed in the distal end of outer shaft 102. Alternatively, tapered portion 207 may be made as a separate element that is subsequently attached to outer shaft 1-2. Such a separate tapered portion 207 may be formed of metal, thermoplastic or thermoset polymer.
In an embodiment of the present invention, outer shaft 102 of catheter device 100 may be made from multilayer tubing having an inner layer, a reinforcing layer (not shown), and an outer layer or jacket. The inner layer may be manufactured of a high density polyethylen (HDPE) that provides good flexibility and movement of outer shaft 102 over guidewire gripping member 206. In another embodiment, the inner layer may be manufactured of a polyamide with a slippery coating for facilitating movement of guidewire gripping member 206 within outer shaft 102. Those of ordinary skill in the art may appreciate that any one of numerous low-friction biocompatible materials such as, for example, fluoropolymers (e.g., PTFE, PEP), polyolefins (e.g., polypropylene, high-density polyethylene), or polyamides, may be used as the inner layer of outer shaft 102. The reinforcing layer of outer shaft 102 is positioned between the inner layer and outer jacket of outer shaft 102.
The reinforcing layer may extend over the length of outer shaft 102, or for a lesser length thereof. In an embodiment, a braid at a distal tip of outer shaft 102 may reinforce conical/tapered portion 207 of distal end 103, which will retain an inner and outer diameter of distal end 103 when brought into contact with distal end 205 of guidewire gripping member 206. In various embodiments, the reinforcing layer may be formed by braiding multiple filaments or winding at least one filament over the inner layer or by applying a metal mesh over the inner layer, such as a wire or mesh made from 304 stainless steel or nitinol. Braided or wound filaments may comprise high-modules thermoplastic or thermo-set plastic materials, e.g., liquid crystal polymer (LCP), polyester, or aramid polymer e.g. poly-paraphenylene terephthalamide (KevlarŪ from E.I. du Pont de Nemours and Company, Wilmington. Del., U.S.A.). Alternatively, braided or wound filaments may include metal such as tantalum, or a work-hardenable super alloy comprising nickle, cobalt, chromium and molybdenum. The outer jacket of outer shaft 102 covers the reinforcing layer, and in embodiments of the present invention, may be manufactured of a polyamide, such as a polyether block amide copolymer or nylon 66.
Guidewire gripping member 206 is manufactured from a thin-walled tubing that is flexible enough to navigate the tortuous pathways of the cardiovascular system while being longitudinally incompressible enough to allow distal end 205 of guidewire gripping member 206 to be advanced and longitudinally forced against the inside of tapered portion 207 of outer shaft 102 to contact and grip guidewire 104. In an embodiment, guidewire gripping member 206 may be made from a thin-walled polyimide tube. In another embodiment, the thin-walled tubing may be a co-extrusion having polylene, or a copolymer thereof, as an inner layer and a stiffer material, such as nylon as an outer layer to impart pushability to guidewire gripping member 206. Slots 208 are then cut within a distal end of the tubing to form gripping jaws or fingers 211, as described above.
While various embodiment according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art than various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiments discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publication discussed herein are incorporated by reference herein in their entirety.
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|Cooperative Classification||A61M25/09041, A61M2025/09125|
|Nov 13, 2006||AS||Assignment|
Owner name: MEDTRONIC VASCULAR, INC.,CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:GUINAN, TERRY;REEL/FRAME:018510/0692
Effective date: 20061108
|Oct 19, 2010||CC||Certificate of correction|
|Sep 23, 2013||FPAY||Fee payment|
Year of fee payment: 4